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从研究人员的角度看,在安全网机构开展人体受试者研究的障碍与促进因素。

Barriers and facilitators to conducting human subjects research at a safety net institution from the perspective of researchers.

作者信息

Barnes Sarah J, Na Yewon, Drainoni Mari-Lynn, Linas Benjamin A, Bosch Nicholas A, Tamlyn Autumn L

机构信息

Boston Medical Center, Boston, MA, United States of America.

Boston University of Chobanian & Avedisian School of Medicine, Boston, MA, United States of America.

出版信息

PLoS One. 2025 Jan 8;20(1):e0313530. doi: 10.1371/journal.pone.0313530. eCollection 2025.

DOI:10.1371/journal.pone.0313530
PMID:39775250
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11709291/
Abstract

INTRODUCTION

The COVID-19 pandemic revealed glaring problems with clinical research enterprise. Faced with crisis, several trials opened rapidly but enrolled homogenous populations with few Black, Indigenous, and People of Color (BIPOC) individuals. Inclusive trial enrollment is important to inspire trust and confidence in BIPOC populations that have been historically excluded or harmed from research and to improve the generalizability of research findings. Safety-net hospitals and institutions often care for BIPOC populations, and thus it is essential to improve equitable participation in research at these institutions. In this study, we sought to understand barriers and facilitators to research participation at safety net institutions.

METHODS

We conducted semi-structured interviews among principal investigators, research assistants, research coordinators, and research nurses who conducted human subjects research at an urban, safety-net hospital from October, 2022 to December, 2022. We used inductive qualitative methods to identify themes associated with barriers and facilitators to clinical research participation.

RESULTS

We completed 28 interviews and identified five themes: (1) compared to non-safety net systems, safety-net systems were perceived to require additional resources and funding to achieve comparable research recruitment and retention; (2) language barriers and translational processes are burdensome for researchers; (3) interactions between research staff and patients impact trust; (4) social determinants of health specific to safety-net populations are a barrier to participation; (5) competing priorities between clinical staff and researchers exist.

CONCLUSION

Safety net institutions face several barriers to conducting human subjects research. However, identified facilitators may help inform future efforts to reduce inequities in research participation.

摘要

引言

新冠疫情暴露出临床研究领域存在的严重问题。面对危机,多项试验迅速启动,但招募的人群同质化,黑人、原住民和有色人种(BIPOC)个体很少。包容性的试验招募对于激发历史上被排除在研究之外或在研究中受到伤害的BIPOC人群的信任和信心,以及提高研究结果的普遍性非常重要。安全网医院和机构通常为BIPOC人群提供护理,因此提高这些机构在研究中的公平参与至关重要。在本研究中,我们试图了解安全网机构研究参与的障碍和促进因素。

方法

2022年10月至2022年12月,我们对在一家城市安全网医院开展人体研究的主要研究者、研究助理、研究协调员和研究护士进行了半结构化访谈。我们采用归纳定性方法来确定与临床研究参与的障碍和促进因素相关的主题。

结果

我们完成了28次访谈,并确定了五个主题:(1)与非安全网系统相比,安全网系统被认为需要额外的资源和资金才能实现可比的研究招募和保留率;(2)语言障碍和翻译过程给研究人员带来负担;(3)研究人员与患者之间的互动影响信任;(4)安全网人群特有的健康社会决定因素是参与的障碍;(5)临床工作人员和研究人员之间存在相互竞争的优先事项。

结论

安全网机构在开展人体研究方面面临若干障碍。然而,已确定的促进因素可能有助于为未来减少研究参与不平等的努力提供参考。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f65/11709291/929f9ea4b115/pone.0313530.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f65/11709291/929f9ea4b115/pone.0313530.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f65/11709291/929f9ea4b115/pone.0313530.g001.jpg

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